Treatment of Coronary In-Stent Restenosis (TIS)

• Late lumen loss [ Time Frame: 12 month ] [ Designated as safety issue: No ]
  Late loss was defined as the minimal vessel lumen diameter immediately after the procedure minus the lumen diameter at angiographic follow-up
  
  

• Major Adverse Cardiac Events [ Time Frame: 12 month ] [ Designated as safety issue: Yes ]
  Major Adverse Cardiac Events are defined as cardiovascular death, acute myocardial infarction or target vessel revascularisation
  
  

• Binary restenosis [ Time Frame: 12 month ] [ Designated as safety issue: No ]
  Binary restenosis is defined as a > 50% diameter stenosis at angiographic follow-up.
  
  

In-stent restenosis after coronary angioplasty is currently one of the main limitations of this method, leading to a recurrence of exertional angina pectoris or manifesting as acute coronary syndrome. Histopathologic substrate of in-stent restenosis is neointimal hyperplasia.

Repeated plain balloon angioplasty or using cutting balloon catheters in the treatment of in-stent restenosis does not achieve satisfactory results. Brachytherapy, used in the past, it has also abandoned. The current treatment of in-stent restenosis is the use of drug eluting stents. Local drug released from these stents prevents new neointimal hyperplasia.This treatment carries the risk of late thrombosis (due to delayed neoendotelization) the stent struts and requires rigorous long-term dual antiplatelet therapy with the risk of bleeding complications. The drug-coated balloon catheters provide short-term penetration of the active substance into the vascular wall, leading to the inhibition of hyperproliferation vascular smooth muscle cells, but due to short-term effect they do not affect negatively stent struts neoendotelization. Comparable effects of in-stent restenosis therapy using paclitaxel releasing balloons was demonstrated in comparison with paclitaxel releasing stents, however, the development of drug eluting stents meanwhile progressed. The aim of our study is to compare efficacy of coronary in-stent restenosis therapy using drug eluting paclitaxel-coated balloon catheters with the latest generation of drug eluting stents releasing everolimus. Primary endpoint of our study is late lumen loss, because it represents accurate angiographic parameter predicting the need for repeat revascularisation and thus the clinical benefit for the patient.